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Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs

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Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs Published by authority of the Minister of Health Date Adopted 2010-03-05 Revised Date 2016-11-14 Administrative Changes Date 2017-04-20 Health Products and Food Branch Information and Submission Requirements for Health Canada Biosimilar Biologic Drugs Guidance document Our mission is to help the people of Canada Our mandate is to take an integrated approach to managing maintain and improve their health. the health-related risks and benefits of health products and Health Canada food by: minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and, promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. Health Products and Food Branch © Her Majesty the Queen in Right of Canada as represented by the Minister of Health, 2017 Available in Canada through Health Canada – Publications Address Locator 0900C2 Ottawa, Ontario K1A 0K9 E-mail: [email protected] Telephone: 613-957-2991, 1-866-225-0709 Web address: www.hc-sc.gc.ca/index-eng.php Également disponible en français sous le titre : Ligne directrice - Exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaire ii Revised Date: 2016-11-14 Health Canada Information and Submission Requirements for Guidance document Biosimilar Biologic Drugs Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents. Revised Date: 2016-11-14 i Information and Submission Requirements for Health Canada Biosimilar Biologic Drugs Guidance document Document Change Log Version Change made Date 1 Initial issuance of document 2010-03-05 2 Comprehensive revision 2016-11-14 3 2.3.5 Labelling requirements - 2017-04-20 Product Monograph Section revised with reference to the Product Monograph Template - Schedule D - Biosimilar Biologic Drug added ii Revised Date: 2016-11-14 Health Canada Information and Submission Requirements for Guidance document Biosimilar Biologic Drugs Table of Contents 1. Introduction ................................................................................................................. 1 1.1 Objective ............................................................................................................. 1 1.2 Scope and application ......................................................................................... 1 1.3 Policy statements ................................................................................................ 2 1.4 Definitions ........................................................................................................... 3 1.5 Background ......................................................................................................... 4 2. Guidance for implementation ..................................................................................... 5 2.1 General ................................................................................................................ 5 2.1.1 Applicable regulations ................................................................................ 5 2.1.2 Patents, intellectual property, and data protection ...................................... 5 2.1.3 Reference biologic drug .............................................................................. 6 2.1.4 Review time ................................................................................................ 7 2.2 Information requirements for clinical trial applications (CTA) .......................... 7 2.3 Information requirements for new drug submissions (NDS) .............................. 8 2.3.1 Organization of data .................................................................................... 8 2.3.2 Quality information ..................................................................................... 8 2.3.3 Non-clinical and clinical information ....................................................... 14 2.3.4 Authorization of indications ..................................................................... 19 2.3.5 Labelling requirements - Product Monograph .......................................... 20 2.3.6 Risk Management Plan ............................................................................. 21 2.4 Post-market requirements ................................................................................. 21 2.4.1 Adverse drug reaction (ADR) reporting and periodic reports .................. 21 2.4.2 Post-notice of compliance (NOC) changes ............................................... 22 3. Consultation with the Biologics and Genetic Therapies Directorate (BGTD) ......... 22 4. Additional Information ............................................................................................. 23 Revised Date: 2016-11-14 iii Health Canada Information and Submission Requirements for Guidance document Biosimilar Biologic Drugs 1. INTRODUCTION Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada, recognises that with the expiration of patents for biologic drugs, manufacturers may be interested in pursuing subsequent entry versions of these biologic drugs. The term biosimilar biologic drug, hereafter referred to as biosimilar, is used by Health Canada to describe subsequent entry versions of a Canadian approved innovator biologic with demonstrated similarity to a reference biologic drug. Biosimilars were previously referred to as Subsequent Entry Biologics (SEBs) in Canada. 1.1 Objective The objective of this document is to provide guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Part C of the Food and Drug Regulations for the authorization of biosimilars in Canada. 1.2 Scope and application This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical package as part of the submission. The following criteria determine the scope of products that are eligible to be authorized as biosimilars: a suitable reference biologic drug exists that: a) was originally authorized for sale based on a full quality, non-clinical and clinical data package; and b) has been used in the post market setting such that the demonstration of similarity will bring into relevance a substantial body of reliable data on safety, efficacy and effectiveness; the biosimilar and reference biologic drug can be well characterized by a set of modern analytical methods; the biosimilar, through extensive characterization and analysis, can be judged similar to the reference biologic drug by meeting an appropriate set of pre-determined criteria. The demonstration of similarity depends upon detailed and comprehensive product characterization. This guidance applies to biologic drugs that contain, as their active substances, well characterized proteins derived through modern biotechnological methods such as use of recombinant DNA and/or cell culture. Biosimilars employing clearly different approaches to manufacture than the reference biologic drug may be eligible; however, careful consideration should be given to expression system Revised Date: 2016-11-14 1 Information and Submission Requirements for Health Canada Biosimilar Biologic Drugs Guidance document differences that may present challenges to demonstrating similarity to the reference biologic drug. In this guidance document, “must” is used to express a requirement that the user is obliged to satisfy in order to comply with the regulatory requirements; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the guidance document. 1.3 Policy statements The following statements outline the fundamental concepts and principles of the regulatory framework for biosimilars: 1.3.1 The
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